Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Felicity Thomas

Demand for intranasal drug delivery methods has been spurred on by various factors, such as the rising prevalence of allergic rhinitis cases and asthma. As a convenient, non-invasive, alternative route of administration, continued growth in the sector has been forecasted by market researchers (1).

Dr. Ferrer BioPharma—a Florida, US-based company that was founded in 2020—is focused on innovation in the field of intranasal medicines through the use of nanoparticle technology. During CPHI Barcelona 2023, 

 spoke with Dr. Ferrer BioPharma’s CEO, Gustavo Ferrer, to learn more.

“Dr. Ferrer BioPharma is a company that was originated by a group of clinicians/doctors and the whole idea was to look into how we can improve the medications that are delivered into the upper airways—the nose and the respiratory system,” Ferrer specified.

Over a decade ago, Ferrer explained that he and his colleagues started looking into specific things that were bothering patients and clinicians around treatment. Collating the information that was gathered into a book, it became apparent that with over-the-counter medicines that were being consumed, neither the patient nor clinician fully understood what they were using, Ferrer continued.

Using the collected data, it was then possible to start working on optimized medications and associated delivery systems, Ferrer stated. “And, [we are] looking into ways of integrating the delivery service more as well,” he said.

The inaugural Start-Up Market at CPHI Barcelona 2023 has been a great success, according to Ferrar. “[The market] gave us access to presenting our information on our data, discussing with big companies, big tech companies that are looking into new innovations that are coming to CPHI,” he asserted.

Next year’s start-up area should be even more well attended in Ferrar’s opinion. “This is the first time that CPHI has done this [start-up area], and I think it has been highly successful,” he said. “I think, next year, in Milan, you’re going to see a lot more [start-ups].”

In the future, Ferrar noted that Dr. Ferrar BioPharma will continue to optimize drug delivery, providing solutions for medicines to be available with less side effect, so, the pathway to the consumer is shorter. “Our goal in the next few years is to get into the European market,” he revealed.

Nasal Drug Delivery Technology Market Report 2023–2033.

Dr. Ferrer BioPharma was featured at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023. CPHI Barcelona ran from Oct. 24–26, 2023.

Videos

Pharmaceutical Technology Europe® spoke with Gustavo Ferrer from Dr. Ferrer BioPharma, a US company focused on innovative intranasal medications, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

Improving Intranasal Treatments with Dr. Ferrer BioPharma at CPHI Barcelona

Throughout many industries, continuous manufacturing has proven to be advantageous when compared with traditional batch processing, providing a faster, cheaper, and more flexible option. Within the pharmaceutical industry, there has been some adoption of continuous manufacturing processes; however, a fully end-to-end continuous pharmaceutical process is still challenging (1).

For CONTINUUS Pharmaceuticals—a spin out company from a multi-year collaboration between MIT and Novartis—producing drugs effectively and at a lower cost has been the primary mission. To learn more about the company and how it is enabling end-to-end continuous manufacturing, 

 spoke with the company’s senior marketing manager, Leonardo Vincenzi, at CPHI Barcelona 2023.

"We specialize in process development,” explained Vincenzi. “We have developed, over the years, a plethora of enabling technologies to allow the continuous manufacturing of pharmaceuticals.”

Generally dealing with large pharmaceutical companies, Vincenzi pointed out that CONTINUUS Pharmaceuticals provides process development technology that allows their customers to convert their batch manufacturing systems into continuous ones.

Recently, CONTINUUS Pharmaceuticals has worked with the United States government in response to the COVID-19 pandemic and to aid in the manufacture of some of the drugs that were in shortage, Vincenzi revealed.

“One of the class of drugs that were challenging for us and pushed us to develop new technologies were high-potency products and controlled substances,” Vincenzi said. “Therefore, we developed new technology and new labs for us to work on these kinds of products.”

For Vincenzi, the key differentiating factor for CONTINUUS Pharmaceuticals is the fact that they are offering an end-to-end solution, something that he hasn’t seen anywhere else. “We go from the raw material to your preferred drug product, all the way through your reaction, filtration, drying steps to the final tableting or vial filling,” he remarked.

1. Domokos, A.; Nagy, B; Szilágyi, B.; Marosi, G.; Nagy, Z.K. Integrated Continuous Pharmaceutical Technologies—A Review. 

CONTINUUS Pharmaceuticals was featured at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023. CPHI Barcelona ran from Oct. 24–26, 2023.

Pharmaceutical Technology Europe® spoke with Leonardo Vincenzi from CONTINUUS Pharmaceuticals, a US company that specializes in process development, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

Converting to Continuous Manufacturing with CONTINUUS Pharmaceuticals at CPHI Barcelona

Retro classic typewriter from circa 1950s with sheet of paper and aged books on wooden desk front aquamarine wall background. Nostalgic writer's work place concept. Vintage old style filtered photo | ©BrAt82 - stock.adobe.com

Ensuring drugs are safe when administered is of utmost importance to the pharma industry. For inhalation drugs, there are strict regulations that must be followed to ensure the drug can be inhaled safely and without any negative or damaging effects. Currently, animal models are commonly used for the safety assessments of inhalation drugs; however, such models are not accurate at predicting how the drug will interact in a human. Another technique for safety assessment is the use of human cells that are taken by lung scraping, which is an invasive process and only provides tissue from the upper lung.

To overcome the limitations of the current approaches, a three-dimensional (3D) human lung model has been developed. The approach, which was originally developed by Abigail Martin while she was working on her PhD research at the University of Hertfordshire, involves the growth of human lower lung tissue and immune cells in a laboratory so that a 3D model can be created. The model can then be used in the place of animal testing and allow companies to test the impact of their drug product on the small airways and inflammation in the lung in a reproducible and more reliable way.

“Having worked on drug development projects that involve animal testing, I’ve seen the difference that new drugs can make to patients’ lives. However, I felt there had to be a better way and set out to look for an alternative,” explained Martin in a press release (1). “Our model not only enables companies to move away from animal testing but also improves safety for patients too. We look forward to working with many more clients and scaling the business with a view to global expansion in the future.”

After having developed the model, Martin collaborated with her PhD supervisor, Victoria Hutter, to set up the company ImmuONE. In efforts to scale up and expand their operations, Martin and Hutter have managed to raise £2 million in investment, securing backing from the MEIF Proof of Concept and Early Stage Fund, which is managed by Mercia Ventures and part of the Midlands Engine Investment Fund.

Hopefully, with this novel approach for safety assessments in inhalation drugs gaining traction, industry can move closer to a future where animal testing is avoided completely for drug products.

ImmunONE. Scientists Raise £2M for 3D Human Lung Model to Replace Animal Testing. ImmunONE.com, News Release, 26 Oct. 2023.

When referring to this article, please cite it as Thomas, F. Breathing Easier. 

Articles

A novel approach for safety assessments in inhalation drugs may avoid animal testing for drug products.

Breathing Easier

Visual inspection is an integral process in the production of filled and sealed pharmaceutical products to ensure there are no particles or contaminants in the finished parenteral dosage form. Currently, both manual and automated processes are used for visual inspection; however, automated systems can be expensive to implement and not always accessible for smaller companies dealing with smaller batch sizes.

Accessibility of automated visual inspection solutions is a key focus for Luo Automation, a Dutch company researching, developing, and producing automated visual inspection machines. To learn more about the company and how it is making visual inspection more accessible, 

 spoke with the company’s founder, Joren van der Horst, at CPHI Barcelona 2023.

"We make visual inspection [solutions] for very small batches,” explained Horst. As with all visual inspection technologies, the primary aim is to check the quality of the medicine and make sure there are no foreign particles or contaminants present, he added.

To perform the inspection, the finished dosage form—syringes, ampoules, and vials—are swirled and then any movement of particles within can be detected, Horst continued. “Another cool thing is the [current interest] in artificial intelligence and machine learning,” he said. “We use machine learning algorithms that are pretty new to also detect static defects. So, not only particles but also leakages and such.”

For Horst, a major differentiator for Luo Automation within industry is the focus on smaller-scale inspection. “If you want, you can buy a huge inspection machine that will cost you a couple of million, but then you need to produce 100 million containers per year,” he stressed. “But, if you have clinical trials or personalized medicine, you cannot [perform the inspection] with a huge machine.”

Luo Automation was featured at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023. CPHI Barcelona ran from Oct. 24–26, 2023.

Pharmaceutical Technology Europe® spoke with Joren van der Horst from Luo Automation, a Dutch company focused on automated visual inspection solutions, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

Making Visual Inspection Accessible with Luo Automation at CPHI Barcelona

Within the highly regulated pharma industry, adoption of new technologies is generally slower than in other industries, as such, despite three-dimensional (3D) printing being available for some time now, its use in the production of medicines is still very much a novelty. However, 3D printing technology has a great potential within the pharma industry, particularly for personalized medicines.

FABRX, a small start-up company that was created by academics from the University College London in the United Kingdom, is focused on the use of 3D technologies in the future of medicine. At CPHI Barcelona 2023, 

 spoke with Carlos Rial Calvo, lead software engineer of FABRX AI—a subsidiary of FABRX based in Spain and started in 2023—to learn more.

“Our aim is to personalize medicine for patients,” explained Rial Calvo. “This is very useful, for example, for highly potent drugs that require very specific dosing.” Additionally, using 3D printing technology to personalize medicine is very useful for pediatrics, who can find swallowing medication difficult, so, Rial Calvo pointed out that it is possible to produce medication that is easier for children to adhere to.

Similarly, for patients that need to take multiple tablets, Rial Calvo noted that with the 3D technology it is possible to create polypills—a combination of different APIs in one printlet (3D printed tablet). “We create polypills, and then [the] patient only has to take one tablet,” he said.

FABRX is currently collaborating with hospitals across Europe, Rial Calvo specified. “For example, we are running a clinical trial in an [oncology] hospital in France to combine an anti-cancer drug with a drug for the side effects [of the cancer treatment] into the same pill,” he stated (1).

In another clinical study, the company has worked with the University of Santiago de Compostela and the University Hospital in Santiago de Compostela in Spain to develop a 3D printed medicine for a rare disease, Rial Calvo revealed. For this study, FABRX prepared doses of isoleucine for children with maple syrup urine disease—an inherited metabolic disorder (2). Using the 3D printing technology, flexible production of a personalized dosage form was possible.

“We provide the software for controlling the machines, but also the software provides features to help with the development of new formulations,” Rial Calvo concluded. “So, the researchers can use our software as well, with the machine, to test new materials.”

1. FABRX. FabRx and Gustave Roussy Enter into an Agreement to Develop a Novel, Personalised, Multi-Drug Dosage Form for the Treatment of Patients with Early-Stage Breast Cancer. 

, Press Release, June 25, 2021.
2. FABRX. FabRx Performs the First Clinical Study Using Personalised 3D Printed Dosage Forms to Treat Children with a Rare Metabolic Disease. 

Fabrx was featured at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023. CPHI Barcelona ran from Oct. 24–26, 2023.

Pharmaceutical Technology Europe® spoke with Carlos Rial Calvo from FABRX, a pharmaceutical 3D printing company, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

3D Printing Medicines with FABRX at CPHI Barcelona

Encapsulating active ingredients within microspheres has proven to be an effective approach to drug delivery. Not only does the coating of the API provide protection against degradation, but it is also possible for developers to control the release of the active ingredient over a set amount of time.

A spin-off company from the University of Twente in The Netherlands, IamFluidics, is pioneering a new technology called in-air microfluidics, which is precise and scalable, as well as being more sustainable than traditional microencapsulation approaches. At CPHI Barcelona 2023, 

 spoke with Dr. Tom Kamperman, co-founder and chief technology officer of IamFluidics, to learn more.

“We work on microfluidics, and the microparticles are difficult to see; they are very small,” Kamperman said. “The active ingredients [are] not stable [and so] we want to stabilize them by encapsulating them, creating a protective shell, like wearing a coat.”

However, once the product is administered, the ‘coat’ should come off to allow the functional ingredients to perform their jobs, Kamperman explained. “Basically, that is what we do.”

Microencapsulation can also help formulators to overcome issues such as poor solubility, Kamperman remarked. “Hydrophobic components can be encapsulated in a hydrophilic shell to make them compatible with a hydrophilic base, or vice-versa,” he said.

As an example, Kamperman highlighted a proof of concept with curcumin as a hydrophobic antioxidant. “[Curcumin] is very difficult to solubilize and to put into formulations,” he stressed. “But, when we encapsulate it, [curcumin] can be easily mixed throughout aqueous formulation and also absorption is much better.”

IamFluidics have developed a few products that are ready to be commercialized, but to develop further, the company is seeking out partnerships. “We are looking for partners to further develop and bring to market the air microfluidics technology that we have,” Kamperman confirmed. “It's a microfluidics microencapsulation technology that has a lot of potential and we need people to collaborate with us to make it big.”

IamFluidics was featured at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023. CPHI Barcelona ran from Oct. 24–26, 2023.

Pharmaceutical Technology Europe® spoke with Dr. Tom Kamperman from IamFluidics, a Dutch high-tech company that develops customized microencapsulation solutions, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.